国家神经系统疾病临床医学研究中心数据管理与共享系统

Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

《国家中心数据管理与共享系统操作说明书 —— 研究者部分》

Effect of Estimated Glomerular Filtration Rate Decline on the Efficacy and Safety of Clopidogrel With Aspirin in Minor Stroke or Transient Ischemic Attack CHANCE Substudy (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events)

第一作者：Yilun Zhou,Yuesong Pan

通讯作者：Yilong Wang,Yongjun Wang

chronic kidney disease clopidogrel stroke

基本信息

2016-11-19

已发表文章

发表杂志：Stroke

发表类型: Original Contributions

影响因子(IF): 7.914

PMID: 2016;47:2791-2796. Pubmed原文链接 全文下载

主要研究背景及目的

Patients with chronic kidney disease (CKD) are at a particularly high risk for ischemic and bleeding events. Limited data exist as to the efficacy and safety of clopidogrel in stroke patients with renal dysfunction. Therefore, we sought to assess the impact of decreased kidney function on clinical outcomes for stroke patients on clopidogrel–aspirin treatment.

方法

Patients in the CHANCE trial (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events) were randomized to clopidogrel–aspirin or aspirin-alone treatment. The primary efficacy outcome was new stroke during 90 days, whereas bleeding was the safety outcome. Patients were stratified according to estimated glomerular filtration rate.

结论

Clopidogrel plus aspirin could decrease new stroke in patients with normal kidney function and mild CKD, but no extra benefit was observed in those with moderate CKD. Bleeding risk from the dual therapy did not seem to increase in mild or moderate CKD patients.

主要结果

Dual clopidogrel–aspirin therapy was associated with a marked reduction in new strokes compared with the therapy of aspirin alone in patients with normal renal function (hazard ratio, 0.77; 95% confidence interval, 0.60–0.98; P=0.02) and mild CKD (hazard ratio, 0.60; 95% confidence interval, 0.45–0.79; P<0.01), whereas in patients with moderate CKD, no significant benefit from clopidogrel therapy was detected (hazard ratio, 1.00; 95% confidence interval, 0.43–2.35; P=0.99). There was no clear difference in bleeding episodes by treatment assignment across categories of renal impairment.